FDA
12th September 2013

FDA Committee Recommends Approval for Anoro Ellipta

GlaxoSmithKline PLC and Theravance, Inc. announced today that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted in favor (11 yes, 2 no) that the efficacy and safety data provided substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25mcg dose) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

FDA Committee Recommends Approval for Anoro Ellipta

GlaxoSmithKline PLC and Theravance, Inc. announced today that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted in favor (11 yes, 2 no) that the efficacy and safety data provided substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25mcg dose) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD, marked by damaged lungs, is the third-leading cause of death in the U.S., according to the National Institutes of Health. The disease, which is primarily caused by smoking, causes the lungs’ airways to become partly obstructed.

In addition, the committee voted that the safety of the investigational medicine has been adequately demonstrated at the 62.5/25mcg dose for the proposed indication (10 yes, 3 no), and the efficacy data provided substantial evidence of a clinically meaningful benefit for UMEC/VI 62.5/25mcg once daily for the long-term, maintenance treatment of airflow obstruction in COPD (13 yes, 0 no).

“Anoro Ellipta” is the proposed proprietary name for UMEC/VI, a combination of two investigational bronchodilator molecules — GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist and vilanterol (VI), a long-acting beta2 agonist, administered using the ELLIPTA inhaler. 

If approved, “Anoro Ellipta” will be the first once-daily dual bronchodilator available in the U.S. Furthermore, UMEC/VI is an investigational medicine that is not currently approved anywhere in the world.

The Advisory Committee’s recommendations will be considered by the FDA in its review of “Anoro Ellipta” however, the FDA is not required to follow the advice of its panel.

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